In this study the effect of bupivacaine injection in the peritoneal cavity in reducing nausea and vomiting after laparoscopic cholecystectomy surgery have been compared with normal saline.
In this randomized double blind clinical trial, 50 patients were enrolled in the study. Patients were in two groups. Inclusion criteria : 20 to 60 years ; ASA class I & II . Exclusion criteria : surgery longer than 2 hour ; Simultaneous surgery ; complication during or past surgery ; motion sickness .
all patients were anesthetized with sodium thiopental 5mg/kg , atracurium ./5 mg/kg , fentanyl 3mic/kg and midazolam ./03 mg/kg . After surgery in the first group,./5 cc/kg saline 0/45% and in the second group 0/5cc/kg bupivacaine 0/5% was injected in the peritoneal cavity . nausea and vomiting were recorded at 1, 2, 6 and 12 hour after surgery with psycometric scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103156071N1
Registration date:2012-12-04, 1391/09/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-04, 1391/09/14
Registrant information
Name
Reza Akhoundzadeh
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 0168
Email address
akhoundzadeh-r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2009-11-13, 1388/08/22
Expected recruitment end date
2010-11-13, 1389/08/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Injection of bupivacaine in reducing nausea and vomiting after laparoscopic cholecystectomy surgery
Public title
Effect of local anesthetics in reducing nausea and vomiting in laparascopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : 20 to 60 years age ; ASA class I & II
Exclusion criteria : surgery longer than 2 hour ; Simultaneous surgery ; complication during or past surgery ; motion sickness
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Shahrak Daneshgah , Golestan
City
Ahvaz
Postal code
Approval date
2010-11-13, 1389/08/22
Ethics committee reference number
ETH _ 013
Health conditions studied
1
Description of health condition studied
Nausea and Vomiting
ICD-10 code
K91.0
ICD-10 code description
Vomiting following gastrointestinal surgery
Primary outcomes
1
Description
Nausea and Voming
Timepoint
1 , 2 , 6 , 12 hour after surgery
Method of measurement
Psychometric Nausea and Vomiting Scale
Secondary outcomes
empty
Intervention groups
1
Description
In Intervention group 0/.5% bupivacaine 0/5 cc /kg was injected in peritoneal cavity at the end of surgery
Category
Treatment - Drugs
2
Description
In control group %0/45 saline 0/5 cc/kg was injected in peritoneal cavity at the end of surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Reza Akhoundzadeh
Street address
Felestin Ave
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Mostafa Feghhi
Street address
Shahrak Daneshgah , Golestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Medicine , Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Reza Akhoundzadeh
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Azadegan avenue , Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
+98 61 1222 0168
Email
akhoundzadeh-r@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Medicine , Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Reza Akhoundzadeh
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Azadegan avenue , Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
+98 61 1222 0168
Email
akhounzadeh-r@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Medicine , Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Sholeh Nesioonpour
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Azadegan avenue , Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
+98 61 1222 0168
Email
akhoundzadeh-r@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)